Our client a Ft Lauderdale based cGMP manufacturer of biotechnology, whose clients include, pharmaceutical, CROs, university and research institutes, government agencies is seeking two Documentation Specialists. These positions are responsible for quality review of completed manufacturing documentation, internal quality audits, and for ensuring that all documents are maintained and issued in compliance with all prevailing cGMP regulations. Other responsibilities include:

• Keep records of documents requested, issued, filed, or removed, using logbooks or computers according to written procedures.
• Track materials removed from files in order to ensure that borrowed files are returned.
• Receive and distribute controlled documents to appropriate individuals and/or departments according to written procedures
• Assign production lot numbers, document control numbers, color codes etc according to written procedures
• Find, retrieve, file, scan, copy or store information from paper and electronic files in compliance with written or otherwise established procedures.
• Compile, sort and verify the accuracy of data before it is entered; detect and report errors
• Check completed work for spelling, grammar, punctuation, and format.
• Determine if written procedures were or were not adequately followed, report to management.

Requirements: 

R     BS/BA degree

R     2+ years in a cGMP environment

R     CFR 210 and 211 cGMPs

Interested?  Email your resume to Jennifer@mriweston.com or call 954-385-3122